The Influence of Intensive Education and Coaching on Compliance for Oral Ganciclovir in the Prophylaxis of CMV: an Open Randomised Trial
1 other identifier
interventional
21
1 country
1
Brief Summary
21 patients were randomised to receive instructions and coaching or no intervention on the use and intake of ganciclovir. Intake of medication was measured by an electronic pill box. The duration of the study was 100 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2001
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 30, 2007
CompletedFirst Posted
Study publicly available on registry
December 3, 2007
CompletedDecember 6, 2007
December 1, 2007
November 30, 2007
December 4, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
relation between compliance of medication towards chemoprophylaxis and occurrence of CMV infection after kidney transplantation
weekly follow-up
Secondary Outcomes (1)
relation between compliance and the instructions which a patient gets about intake of medication
weekly follow-up
Study Arms (2)
1
EXPERIMENTALinstructions and coaching on the use and intake of ganciclovir
2
NO INTERVENTIONInterventions
instructions and coaching or no intervention on the use and intake of ganciclovir
Eligibility Criteria
You may qualify if:
- men and women between 18 and 65 years old
- de novo kidney transplant patients
- patients who need CMV prophylaxis with ganciclovir during 3 months
- patients who gave informed consent after an oral explanation of the study
You may not qualify if:
- patients who are seronegative for CMV virus and who received a kidney from a CMV negative donor
- patients with a creatinin clearance of less than 10 ml/min
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- Hoffmann-La Rochecollaborator
Study Sites (1)
University Hospital Ghent
Ghent, 9000, Belgium
Related Publications (2)
Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.
PMID: 39807668DERIVEDVernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.
PMID: 38700045DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabelle Devolder, MD
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 30, 2007
First Posted
December 3, 2007
Study Start
May 1, 2001
Study Completion
May 1, 2003
Last Updated
December 6, 2007
Record last verified: 2007-12